NCT06926842已完成2 期
A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 49
- 主要终点
- Percentage Change in Body Weight
研究概览
简要总结
The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Male or female participants with body mass index (BMI) ≥27.0 kg/m
- •Diagnosed with type 2 diabetes ≥180 days prior to the day of screening.
- •Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug[s], dose, and dosing frequency) for at least 90 days prior to screening.
排除标准
- •Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
- •Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening.
- •A self-reported change in body weight >5% within 90 days prior to screening, irrespective of medical records.
- •Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 90 days prior to screening.
- •Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed.
- •Obesity due to endocrine disorders or genetic syndromes.
研究组 & 干预措施
Treatment B: Petrelintide Placebo Dose 1
Placebo Comparator
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
干预措施: Placebo (Other)
Treatment A: Petrelintide Dose 1
Experimental
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
干预措施: Petrelintide (Drug)
Treatment C: Petrelintide Dose 2
Experimental
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
干预措施: Petrelintide (Drug)
Treatment D: Petrelintide Placebo Dose 2
Placebo Comparator
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
干预措施: Placebo (Other)
Treatment F: Petrelintide Placebo Dose 3
Placebo Comparator
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
干预措施: Placebo (Other)
Treatment E: Petrelintide Dose 3
Experimental
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
干预措施: Petrelintide (Drug)
结局指标
主要结局
Percentage Change in Body Weight
时间窗: From Baseline (Day 1) to Weeks 28
次要结局
- Number of Participants Achieving ≥5% Body Weight Loss(From Baseline (Day 1) to Weeks 28)
- Number of Participants Achieving ≥10% Body Weight Loss(From Baseline (Day 1) to Weeks 28)
- Change in Body Weight (kilogram)(From Baseline (Day 1) to Weeks 28)
- Change in Waist Circumference(From Baseline (Day 1) to Weeks 28)
- Change in Glycated Hemoglobin (HbA1c)(From Baseline (Day 1) to Weeks 28)
- Change in Fasting Glucose(From Baseline (Day 1) to Weeks 28)
- Change in High-Sensitivity C-reactive protein (hsCRP)(From Baseline (Day 1) to Weeks 28)
- Number of Participants Achieving ≤6.5% HbA1c(From Baseline (Day 1) to Weeks 28)
- Changes in Fasting Lipids(From Baseline (Day 1) to Weeks 28)
- Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38(From Baseline (Day 1) to Weeks 38)
- Change in Systolic Blood Pressure(From Baseline (Day 1) to Week 38)
- Change in Diastolic Blood Pressure(From Baseline (Day 1) to Week 38)
- Change in Pulse Rate(From Baseline (Day 1) to Week 38)
- Change in Fasting Glucose(From Baseline (Day 1) to Weeks 28)
- Number of Participants Achieving ≥5% Body Weight Loss(From Baseline (Day 1) to Weeks 28)
- Number of Participants Achieving ≥10% Body Weight Loss(From Baseline (Day 1) to Weeks 28)
- Change in Body Weight (kilogram)(From Baseline (Day 1) to Weeks 28)
- Change in Glycated Hemoglobin (HbA1c)(From Baseline (Day 1) to Weeks 28)
- Change in Waist Circumference(From Baseline (Day 1) to Weeks 28)
- Change in High-Sensitivity C-reactive protein (hsCRP)(From Baseline (Day 1) to Weeks 28)
- Number of Participants Achieving ≤6.5% HbA1c(From Baseline (Day 1) to Weeks 28)
- Changes in Fasting Lipids(From Baseline (Day 1) to Weeks 28)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From Baseline (Day 1) to Weeks 38)
- Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38(From Baseline (Day 1) to Weeks 38)
- Number of Participants with Positive Anti-Drug Antibodies (ADAs)(From Baseline (Day 1) to Weeks 38)
- Change in Systolic Blood Pressure(From Baseline (Day 1) to Week 38)
- Change in Diastolic Blood Pressure(From Baseline (Day 1) to Week 38)
- Change in Pulse Rate(From Baseline (Day 1) to Week 38)
研究者
研究点 (49)
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